GBI TSH NEONATAL SCREENING KIT— 510(k) K072458
Substantially EquivalentGolden Bridge International, Inc.
FDA 510(k) clearance K072458 for GBI TSH NEONATAL SCREENING KIT, Substantially Equivalent on 2008-04-10. Applicant: Golden Bridge International, Inc..
Clearance details
- Applicant
- Golden Bridge International, Inc.
- Product code
- Code JLW
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mukilteo, WA, US
Adverse events under product code JLW
product code JLW- Malfunction
- 885
- Total
- 885
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.